Condition or disease | Intervention/treatment | Phase |
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Vaccination; Complications Vaccine Adverse Reaction Fear | Other: Multi-faceted knowledge translation intervention | Not Applicable |
The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation.
Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 7800 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included. |
Masking: | Single (Participant) |
Masking Description: | Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained in the intervention will not deliver care to participants in the intervention group |
Primary Purpose: | Treatment |
Official Title: | Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial |
Actual Study Start Date : | May 22, 2019 |
Estimated Primary Completion Date : | June 2020 |
Estimated Study Completion Date : | August 2020 |
Arm | Intervention/treatment |
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Experimental: CARD (multi-faceted knowledge translation intervention)
CARD will be integrated into the school vaccination program. This includes pre-vaccination day preparation (e.g., planning of clinic spaces, student and school staff education about CARD) and vaccination day activities (e.g., clinic set-up, processes for triaging students, implementing pain/ fear/fainting mitigation interventions from CARD during vaccination)
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Other: Multi-faceted knowledge translation intervention
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Other Name: CARD
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No Intervention: Control (standard care)
There are no specific procedures being undertaken to plan or execute clinics. Usual practices will be instituted (i.e., no education specific to CARD, nor clinic set-up or execution to incorporate interventions for pain, fear or fainting)
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Ages Eligible for Study: | 11 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
- unable to understand and read English
Canada, Alberta | |
Alberta Health Services Public Health - Calgary Zone | |
Calgary, Alberta, Canada, T2W 3N2 |
Principal Investigator: | Anna Taddio, PhD | University of Toronto |
Tracking Information | |||||
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First Submitted Date ICMJE | May 25, 2019 | ||||
First Posted Date ICMJE | May 29, 2019 | ||||
Last Update Posted Date | June 12, 2020 | ||||
Actual Study Start Date ICMJE | May 22, 2019 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Student fear [ Time Frame: within 5 minutes after vaccination ] student self-reported fear during vaccination, rated on a 0-10 scale
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Effectiveness of CARD for Improving School-Based Immunizations | ||||
Official Title ICMJE | Effectiveness of a Multi-faceted Knowledge Translation Intervention (The CARD System) for School Based Immunizations: a Cluster Trial | ||||
Brief Summary | Vaccination is estimated to have saved more lives in Canada than any other single intervention and is considered one of the most important advances in the prevention of disease. The process of vaccination, however, is stressful for individuals. School-based vaccinations in particular, are associated with high levels of fear and anxiety among students. This randomized cluster trial will implement a multi-faceted knowledge translation intervention called The CARD (C-Comfort A-Ask R-Relax D-Distract) System in school-based vaccinations and evaluate its effects on the experience of vaccination for students and implementation outcomes. | ||||
Detailed Description |
The investigators developed a multi-faceted knowledge translation intervention called The CARD System to provide a framework for delivering vaccinations at school that integrates evidence-based strategies to mitigate pain, fear and fainting and promotes a student-centred approach to vaccination. CARD addresses 2 components of the vaccination delivery program: 1) pre-vaccination day preparation and 2) vaccination day activities. In a small controlled clinical trial in a public health unit in Niagara, Ontario, the investigators demonstrated benefits of CARD on student symptoms during vaccination, including fear, and dizziness-precursor of fainting, and satisfaction with CARD by all stakeholder groups (students, public health staff, school staff and parents). This study will evaluate CARD in a large cluster trial in Calgary, Alberta. This trial is the final phase of a 3-phase project, whereby the first 2 phases involve developing an implementation plan for the local context and evaluating feasibility of implementation. Eight community health centres that provide vaccination services to schools in their regions will be randomized in a 1:1 ratio to CARD or control (usual practices). Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Cluster trial involving 8 community health centres. They will be randomized to CARD or control (standard care) groups in a 1:1 ratio. Eligible schools (approximately 13/community health centre) will be included. Masking: Single (Participant)Masking Description: Students will not be aware of whether they are in the intervention or control group. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are trained in the intervention will not deliver care to participants in the control group and care providers that are not trained in the intervention will not deliver care to participants in the intervention group Primary Purpose: Treatment
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Condition ICMJE |
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Intervention ICMJE | Other: Multi-faceted knowledge translation intervention
The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
Other Name: CARD
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Suspended | ||||
Estimated Enrollment ICMJE |
7800 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 2020 | ||||
Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: - unable to understand and read English |
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Sex/Gender ICMJE |
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Ages ICMJE | 11 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03966391 | ||||
Other Study ID Numbers ICMJE | 036893 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Anna Taddio, University of Toronto | ||||
Study Sponsor ICMJE | University of Toronto | ||||
Collaborators ICMJE | Alberta Health Services | ||||
Investigators ICMJE |
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PRS Account | University of Toronto | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |